ApexCut Blade with Automated EM Tracking (6 models)— 510(k) K262235
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K262235 for ApexCut Blade with Automated EM Tracking (6 models), Substantially Equivalent on 2026-09-04. Applicant: Medtronic Xomed, Inc.. Device class: 2.
Clearance details
- Device name as filed
- ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM)
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code PGW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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Adverse events under product code PGW
product code PGW- Malfunction
- 1,199
- Total
- 1,199
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.